Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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No Description
Thought Technology Ltd.
SA9030
In Commercial Distribution

  • 07540191000586 ()


  • Psychophysiological biofeedback system
  • Physical therapy transcutaneous neuromuscular electrical stimulation system
  • Perineal orifice incontinence-control electrical stimulation system probe, reusable
No Description
Thought Technology Ltd.
SA9013
In Commercial Distribution

  • 07540191000548 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
  • Psychophysiological biofeedback system
  • Perineal orifice incontinence-control electrical stimulation system, professional
No Description
Thought Technology Ltd.
SA4502
In Commercial Distribution

  • 07540191000487 ()


  • Psychophysiological biofeedback system
Dream Sock Software App. The Dream Sock is intended for over-the-counter (OTC) use only in a home environment. It is not intended to provide notification for every episode of the unexpected occurrences of elevated or depressed PR or a low SpO2 level; rather, the Dream Sock is intended to provide a notification only when sufficient data are available for analysis. The notifications and associated data can be used to supplement the decision by caregivers to seek additional guidance for medical care of the infant. The Dream Sock is not intended to replace traditional methods of monitoring, diagnosis or treatment.
Owlet Baby Care, Inc.
3.0
In Commercial Distribution

  • 00810099090819 ()


  • Multiple vital physiological parameter monitoring system, home-use
No Description
Sonova AG
088-0021
In Commercial Distribution

  • 07613389543254 ()


  • Audiometric/hearing device software
No Description
Nox Medical ehf.
NOX-NOXTURNAL_US_APP
In Commercial Distribution

  • 15694311111665 ()


  • Sleep disorder interpretive software, professional-only
SW, EXE, Lifeline Response Smart Phone Application, Google
Lifeline Systems Company
300000161331
Not in Commercial Distribution

  • 00884838082137 ()
mSafe

  • Vulnerable patient home alert system
SW, EXE, Lifeline Response Smart Phone Application, Apple
Lifeline Systems Company
300000161311
Not in Commercial Distribution

  • 00884838082120 ()
mSafe

  • Vulnerable patient home alert system
DS Replacement APP Pad (Double
COMPASS HEALTH BRANDS CORP.
DS-APP2
In Commercial Distribution

  • 30092237617695 ()
  • 00092237617694 ()


  • Alternating-pressure bed mattress overlay, reusable
DS Panacea APP & Pad Syst.,
COMPASS HEALTH BRANDS CORP.
DS-APP1-NADJP
In Commercial Distribution

  • 30092237617688 ()
  • 00092237617687 ()


  • Alternating-pressure bed mattress overlay system
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